What side effects are associated with this type of intervention?

Common treatments for osteoarthritis that target pain pathways or inflammation include NSAIDs, intra-articular glucocorticoids, and anti-NGF antibodies. NSAIDs, such as ibuprofen and naproxen, can cause gastrointestinal issues, cardiovascular risks, and renal problems. Intra-articular glucocorticoids may provide short-term pain relief but can lead to joint damage with repeated use. Anti-NGF antibodies, like tanezumab, have been associated with rapidly progressive osteoarthritis and increased rates of joint replacement surgeries. These treatments aim to alleviate pain but come with significant potential side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for osteoarthritis that target pain and inflammation. Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, naproxen, and celecoxib are commonly used for pain relief and inflammation control. Intra-articular corticosteroid injections are also approved for short-term pain relief in patients with moderate to severe osteoarthritis. Additionally, hyaluronic acid injections have been used to provide lubrication and pain relief in the knee joint. While investigational treatments like RTX-GRT7039 are being studied, these existing therapies remain the mainstay of osteoarthritis management.

What other types of research exist?

Promising alternatives to RTX-GRT7039 for osteoarthritis treatment in 2024 include: 1) PTK787/ZK222584, a VEGF receptor tyrosine kinase inhibitor with significant anti-arthritic effects; 2) Novel NSAID-glucosamine bioconjugates, which show potential for reduced gastric toxicity and effective COX-1/COX-2 inhibition; 3) IL-17 inhibitors like secukinumab and ixekizumab, which are effective in reducing inflammation; and 4) JAK inhibitors such as tofacitinib and upadacitinib, which offer another mechanism to manage inflammation and pain. These alternatives provide various mechanisms of action and delivery methods, potentially improving patient outcomes.

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Monoclonal Antibodies

RTX-GRT7039 Injections for Knee Osteoarthritis

Phase 3

Waitlist Available

Research Sponsored by Grünenthal GmbH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The participant is 18 years of age or older at the Screening Visit.

The participant has a diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria and functional capacity class of I to III.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline up to week 12

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial uses knee injections called RTX-GRT7039 for patients with knee osteoarthritis who still have pain despite usual treatments. The injections aim to reduce knee pain, possibly by affecting pain pathways or inflammation.

Who is the study for?

This trial is for adults over 18 with knee osteoarthritis who haven't found pain relief from standard treatments. They must be able to consent to the study and have a functional capacity class of I to III, based on specific medical criteria.

What is being tested?

The trial is testing RTX-GRT7039 injections for knee pain due to osteoarthritis. It's an open-label, single-arm study where all participants receive the treatment to assess its safety and tolerability.

What are the potential side effects?

Since this summary focuses on safety and tolerability, potential side effects may include reactions at the injection site, general discomfort or pain increase in the knee, or other unforeseen responses related to RTX-GRT7039.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

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I have been diagnosed with knee osteoarthritis and can still perform daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change From Baseline in 36-Item Short-Form (SF-36) Domain Scores

Change From Baseline in EuroQol-5 Dimension Health Questionnaire 5 Levels (EQ-5D-5L) Score

Change From Baseline in Patient-Specific Functional Scale (PSFS)

+8 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: RTX-GRT7039Experimental Treatment1 Intervention

Participants will receive injections of RTX-GRT7039 into either the index knee (affected knee or in case of bilateral OA the knee with highest pain intensity), or each of both knees up to Week 52.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for osteoarthritis (OA) include NSAIDs, which inhibit cyclooxygenase enzymes to reduce inflammation and pain, and glucocorticoids, which suppress the immune response to decrease inflammation. Novel treatments like RTX-GRT7039 likely target pain pathways or joint inflammation, similar to other investigational agents that modulate nerve growth factors or inflammatory cytokines. Understanding these mechanisms is essential for OA patients as it helps in selecting appropriate therapies to manage symptoms and enhance quality of life.

Osteoarthritis of the knee - biochemical aspect of applied therapies: a review.New Trends in Pharmacological Treatments for Osteoarthritis.